Back to resultsComparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Primary Purpose
Refractive Errors, Self-Examination
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Smartphone
Autorefractor
Individual
Sponsored by
About this trial
This is an interventional diagnostic trial for Refractive Errors
Eligibility Criteria
Inclusion Criteria:
- existing refractive error
- using glasses or contac lenses
Exclusion Criteria:
- opacities (visus limitating) of cornea, lens or vitreous
- known ocular pathologies except refractive error
- epilepsia
- irregular corneal topography
Sites / Locations
- University Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Main group
Arm Description
Main study group including all individuals that underwent the study procedures
Outcomes
Primary Outcome Measures
Refractive Error
Comparison of refractive error measurements between methods
Secondary Outcome Measures
Visual acuity
Visual acuity of persons using based on different methods.
Personal evaluation of measuring accuracy (Questionnaire)
Would persons be willing to order glasses by using only self-test-results?
Time consumption
Comparison of needed time to reach self-test refraction error results and conservative-test results.
Full Information
NCT ID
NCT03419351
First Posted
December 6, 2017
Last Updated
January 31, 2018
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03419351
Brief Title
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Official Title
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Anticipated)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Self evaluating tools based on smartphone devices are public available on the market for each person. The tools are used to estimate the existing refractive error for each eye of a patient. Hereafter, e.g. ordering glasses via internet could be the next step for this persons.
The daily routine within an eye hospital shows, that estimation of the refractive error is a difficult and time consuming procedure.
The study compares the results of the measured refractive error using a smartphone based tool with the results of conventional measurement methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors, Self-Examination
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Main group
Arm Type
Other
Arm Description
Main study group including all individuals that underwent the study procedures
Intervention Type
Diagnostic Test
Intervention Name(s)
Smartphone
Intervention Description
Smartphone based measurement of refractive error and visual acuity testing using these measurements.
Intervention Type
Diagnostic Test
Intervention Name(s)
Autorefractor
Intervention Description
Autorefractor based measurement of refractive error and visual acuity testing using these measurements.
Intervention Type
Diagnostic Test
Intervention Name(s)
Individual
Intervention Description
Individual, human measurement of refractive error and visual acuity testing using these measurements.
Primary Outcome Measure Information:
Title
Refractive Error
Description
Comparison of refractive error measurements between methods
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Visual acuity of persons using based on different methods.
Time Frame
6 month
Title
Personal evaluation of measuring accuracy (Questionnaire)
Description
Would persons be willing to order glasses by using only self-test-results?
Time Frame
6 month
Title
Time consumption
Description
Comparison of needed time to reach self-test refraction error results and conservative-test results.
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
existing refractive error
using glasses or contac lenses
Exclusion Criteria:
opacities (visus limitating) of cornea, lens or vitreous
known ocular pathologies except refractive error
epilepsia
irregular corneal topography
Facility Information:
Facility Name
University Eye Hospital
City
Tuebingen
State/Province
BW
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin A Leitritz, M.D.
Phone
+49 (0) 7071-29-88088
Email
martin.leitritz@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Martin A Leitritz, M.D.
First Name & Middle Initial & Last Name & Degree
Sebastian Mueller, M.D.
First Name & Middle Initial & Last Name & Degree
Markus Schulze-Schwering, M.D.
12. IPD Sharing Statement
Learn more about this trial
Comparison of a Smartphone Based Self Refraction Tool With Conventional Refraction Error Estimation Methods
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